MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR4; CATHETER, THROMBUS RETRIEVER

Model Number SFR4-4-40-10

Device Problem Break (1069)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 06/04/2022

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the distal part of the solitaire pushwire separated.The proximal part was removed without any device, and the distal part was completely removed with a snare.It was reported that the patient experienced a subarachnoid hemorrhage and died. the devices were prepared according to the instructions for use (ifu).The patient was undergoing treatment for an ischemic stroke located in the middle cerebral artery.One pass was made with the device.Ancillary devices include a 6f cook sheath, phenom 21 microcatheter, and sofia 6f distal access catheter.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received indicating in the first control after removal of the torn material, there was no sign of bleeding.The bleeding was only seen in the control after the second passage with a new stent retriever.The pushwire was torqued during the procedure.There was moderate resistance encountered during the procedure.The patient's vessel tortuosity had usual elongation.The cause of the event was not determined.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: as found condition: the solitaire x revascularization device was returned for analysis within a shipping box; within two sealed plastic biohazard pouches; within a dispenser coil and within an introducer sheath.The phenom-21 micro catheter involved in the event was not returned for analysis.Visual inspection/damage location details: the solitaire x pusher was found broken proximal to the marker coil with the ptfe jacket found damaged.The marker coil was found kinked.The solitaire x stent and attachment core wire were found separated from the pusher.No irregularities were found with the solitaire x proximal marker/attachment zone.No damages or irregularities were found with the solitaire x stent non-working (tear drop) length struts, the working length struts or the marker fingers.No other damages or irregularities were observed.Testing/analysis: n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿pushwire break/separation¿ was confirmed.Possible causes for failure are patient stenosis, vessel tortuosity, pre-existing stent, number of passes made with device, or new micro catheter was not used with each solitaire.Customer reported devices were prepared per ifu, one pass was made with device, pushwire was torqued during procedure, moderate resistance was encountered during procedure, and patient vessel tortuosity had ¿usual elongation¿.It is likely the reported resistance contributed towards the separation.The cause of the resistance could not be determined.As the phenom-21 micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the resistance could not be assessed.The phenom-21 micro catheter has an inner diameter of 0.021¿, which is compatible for use with the solitaire x device.Customer reported that bleeding did not occur until after second pass with a new stent retriever.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: SOLITAIRE FR4
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14655400
• MDR Text Key: 293725776
• Report Number: 2029214-2022-00981
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K183022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SFR4-4-40-10
• Device Catalogue Number: SFR4-4-40-10
• Device Lot Number: B338431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death